check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
100493
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Evaluation the Efficacy and Safety of Vardenafil in subjects with erectile dysfunction for 10 weeks
Trial purpose
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.
Key Participants Requirements
Sex
MaleAge
18 YearsTrial summary
Enrollment Goal
383Trial Dates
December 2003 - August 2004Phase
Phase 3Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoPrimary Outcome
- Per-patient success rates based on Sexual Encounter Profile, Question 3date_rangeTime Frame:10 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Per-subject success rates based on Sexual Encounter Profile, Question 2date_rangeTime Frame:10 weeksenhanced_encryptionnoSafety Issue:
- International Index of Erectile Function- Erectile Function domain scoredate_rangeTime Frame:10 weeksenhanced_encryptionnoSafety Issue:
- Global Assessment Question (GAQ)date_rangeTime Frame:10 weeksenhanced_encryptionnoSafety Issue:
- Safety and tolerabilitydate_rangeTime Frame:10 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2